Duns Number:202659140
Device Description: The Reliance 1227 Cart and Utensil Washer-Disinfector is a high-capacity cart washer inten The Reliance 1227 Cart and Utensil Washer-Disinfector is a high-capacity cart washer intended for cleaning and low-level disinfecting of instrument case carts and other reusable patient items such as bedpans, basins, and containers.
Catalog Number
FW03101
Brand Name
Reliance
Version/Model Number
1227
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MEC
Product Code Name
Disinfector, medical devices
Public Device Record Key
5fca6288-71f7-49b1-9dfd-f79c6f521428
Public Version Date
January 28, 2021
Public Version Number
2
DI Record Publish Date
September 04, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 262 |